Medical Writing Manager Jobs
Medical writing manager jobs are open across pharma, biotech, medical devices, and CROs, from associate manager to senior director level, with specializations in regulatory affairs, clinical documentation, and scientific communications. Find a role that fits below and apply directly.
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Showing 5 of 35+ Medical Writing Manager jobs
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.
Role and Responsibilities:
- Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator's Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed
- Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
- Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
- Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
- Facilitate comment resolution and adjudication with authors, reviewers, and project teams
- Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high- quality medical writing deliverables
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
- 10+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator's brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents
- Knowledge of oncology disease areas preferred
- Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines
- Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
- Excellent attention to detail, multitasking, prioritization, and flexibility
- Excellent communication skills with proven ability to interact in a cross-functional environment
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
- Proficiency in use of MS Office applications, Adobe Acrobat, electronic document management systems, and templates.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
- Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal direction
- Ability to think strategically, be resourceful, and lead with minimal direction
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.
Role and Responsibilities:
- Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator's Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed
- Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
- Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
- Develop and manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
- Facilitate comment resolution and adjudication with authors, reviewers, and project teams
- Participate in the development/refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high- quality medical writing deliverables
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
- 10+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator's brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents
- Knowledge of oncology disease areas preferred
- Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines
- Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness
- Excellent attention to detail, multitasking, prioritization, and flexibility
- Excellent communication skills with proven ability to interact in a cross-functional environment
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
- Proficiency in use of MS Office applications, Adobe Acrobat, electronic document management systems, and templates.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
- Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal direction
- Ability to think strategically, be resourceful, and lead with minimal direction
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Medical Writing Manager Jobs by Experience Level
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Find Medical Writing Manager JobsMedical Writing Manager Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Technology & Software
- Healthcare & Medical Services
What Employers Look For
The qualifications that appear most often in medical writing manager jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, or a related field
- Five or more years of medical writing experience in pharma, biotech, or CRO settings
- Demonstrated experience managing or mentoring a team of medical writers
- Proficiency with regulatory submissions including INDs, NDAs, BLAs, or CTDs
- Strong knowledge of ICH guidelines and FDA or EMA submission standards
- Experience with document management systems and style guide development
Tips for Your Medical Writing Manager Job Search
Tailor your resume to submission types
Hiring managers scan for the document types you have managed: CSRs, INDs, NDAs, briefing documents, or manuscripts. List each type explicitly and note the therapeutic areas covered so reviewers can match your background to their pipeline.
Show your cross-functional leadership record
Medical writing managers are evaluated on how well they direct writers and align with regulatory, clinical, and medical affairs teams. Describe specific projects where you coordinated across functions, not just edited documents or set timelines.
Apply early to roles that fit
Migrate Mate lists medical writing manager openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Filter openings by regulatory pathway
Roles supporting FDA submissions differ from those tied to EMA or ICH guidelines. Identify which regulatory frameworks a posting emphasizes before applying, and align your cover letter to the specific agency context the employer mentions.
Prepare a writing sample set before interviews
Many hiring panels request redacted samples of documents you have managed. Have two or three examples ready, one regulatory and one scientific or medical affairs, with a brief explanation of your editorial and strategic decisions on each.
Negotiate based on document complexity
When discussing compensation, reference the complexity and regulatory stakes of the submissions you have owned, such as BLA modules or advisory committee briefings, rather than team size alone. Document complexity is a recognized driver of scope in this role.
Medical Writing Manager Jobs: Frequently Asked Questions
Which companies are hiring the most medical writing managers?
Veeva Systems, Alkermes, and Faro Health are hiring the most medical writing managers right now, with openings concentrated in California, Massachusetts, and Pennsylvania, based on current listings on Migrate Mate as of August 2026. Demand is especially strong at large pharma companies and CROs managing late-stage clinical pipelines.
How many medical writing manager jobs are remote?
About 91% of medical writing manager openings are fully remote or hybrid as of August 2026, reflecting a strong shift toward distributed teams in this field. Roles focused on scientific communications and publication planning tend to have the highest remote availability, while regulatory-heavy positions often require closer collaboration with on-site clinical and regulatory affairs teams.
How do you become a medical writing manager?
Start by building several years of hands-on medical writing experience in pharma, biotech, or a CRO, focusing on regulatory documents or scientific publications. Take on informal leadership by mentoring junior writers and owning document strategies for major submissions. Pursuing a credential through the American Medical Writers Association can strengthen your profile before moving into a formal management role.
How do you get hired as a medical writing manager with limited management experience?
Emphasize any project leadership you have done, even if it was informal: training a new writer, owning a submission timeline, or coordinating across clinical and regulatory teams on a single document. Highlight the complexity of documents you have managed independently. Employers in smaller biotech companies often hire from within the contributor level when a candidate demonstrates strategic thinking and strong cross-functional communication alongside solid writing credentials.
What does the medical writing manager interview process look like?
Most processes begin with a recruiter or HR screen focused on your regulatory background and team experience, followed by a panel interview with writing directors, regulatory affairs leads, or medical affairs stakeholders. Candidates are frequently asked to walk through a past submission or writing project in detail. Some employers include a written exercise or request redacted document samples. Final rounds often involve a discussion with senior leadership about departmental strategy and pipeline priorities.
Where can I find and apply to medical writing manager jobs?
You can find and apply to medical writing manager jobs on Migrate Mate, which lists current openings from across the United States in one place. Search for roles that match your therapeutic area expertise and regulatory background, then apply directly to each listing that fits your experience and career goals.
See All 35 Medical Writing Manager Jobs
Find roles that match your experience and apply in just a few clicks.
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